(142 days)
No
The document describes standard CT image reconstruction (FBP and iterative reconstruction) and various image processing and analysis tools, but does not mention AI or ML.
No
The device is a diagnostic imaging system (CT scanner) used to create images of the body, not to treat conditions.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device can be used as a "whole body computed tomography X-ray system," and the "Summary of Performance Studies" section mentions that the "Results indicated that the images were of diagnostic quality." This indicates the device is used to diagnose medical conditions.
No
The device description explicitly states that the system is composed of hardware components such as a gantry, patient couch, and operator console, in addition to software. It also mentions image acquisition hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "whole body computed tomography X-ray system." It describes the process of acquiring X-ray transmission data and reconstructing it into cross-sectional images of the body. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body.
- Device Description: The description details the physical components (gantry, couch, console) and software features related to image acquisition, reconstruction, and visualization. These are all functions of a medical imaging system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the NeuViz Prime Multi-Slice CT Scanner System is a medical imaging device, specifically a CT scanner, and not an IVD.
N/A
Intended Use / Indications for Use
The NeuViz Prime Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Product codes
JAK
Device Description
The NeuViz Prime Multi-Slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) and iterative reconstruction algorithm(ClearView cleared in K133373) to reconstruct images. The end user can choose to apply either ClearView or the FBP to the acquired raw data. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. It provides the following digital image processing and visualization tools:
- Support following scan speed: 0.259s(option), 0.32s(option), 0.374s(option), 0.4s(option), 0.5s, 0.6s, 0.8s, 1.0s, 1.5s, 2.0s.
- Surview scan
- Dual surview
- Spiral scan
- Axial scan
- Image reconstruction
- Plan scan
- Patient information management
- Patient information registration
- Protocol selection
- O-Dose
- Bolus tracking
- SAS
- Home
- Film
- Report
- 2D
- MPR
- 3D
- VE(Virtual Endoscopy)
- Vessel Analysis
- Dicom Viewer
- Bar code Reader
- Dual Monitor
- CCT Scan
- ClearView
- iHD
- Cardiac Scan
- Dual Energy Scan and Reconstruction
- Dental Analysis
- Virtual Colonoscopy
- Brain Perfusion
- Body Perfusion
- Lung Nodule Analysis
- Lung Density Analysis
- Coronary Analysis
- Cardiac Calcium Scoring
- Cardiac Function Analysis
- Cardiac Viewer
- Fat Analysis
- CTDSA
- Tumor Assessment
- Preprocessing function
- AVW.Cloud
- Prism Viewer
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) X-ray
Anatomical Site
Whole body, head, brain, chest, abdomen, spine/extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The safety and effectiveness of the NeuViz Prime was assured by adherence to Good Manufacturing Practices(GMP) 21CFR 820 and to International Standards ISO 13485:2003. This device is in conformance with the applicable parts of the following standards: ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 medical electrical equipment -- part 1: general requirements for basic safety and essential performance, IEC 60601-1-2: 2007, IEC 60601-1-3: 2013, IEC 60601-1-6: 2013, IEC 60601-2-28: 2010, IEC 60601-2-44: 2012, IEC 60825-1:2007, IEC 61223-3-5: 2004, AAMI ANSI IEC 62304:2006, IEC 62366:2014, ISO 10993-1: 2009, ISO 14971:2007, NEMA PS 3.1 - 3.20 (2016), NEMA XR 25: 2010, NEMA XR 28: 2013. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements if demonstrated via testing. Testing included functional, smoke and regression tests.
Verification and validation activities (including performance testing, safety testing and simulated use testing) was performed. Some of the bench tests included the sag and the speed of patient support table, the gantry wobble, CT image quality metrics testing including CT number accuracy and uniformity, MTF, noise, slice sensitivity profiles and CTDI. Sample images were provided to show the performance of the system in presence of implants.
The clinical validation plan identified the tasks, deliverables, methodology, requirements and the resources for validation of the intended use and meets customer needs. The clinical validation covered requirements related to clinical workflows and features. The validation was executed as planned and acceptance criteria met for each requirement. All validation tests demonstrate the safety and effectiveness of NeuViz Prime.
Two CT clinical specialists of Neusoft validated the system under simulative clinical circumstances. An image evaluation was performed to evaluate images of the brain, chest, abdomen and spine/extremities of the body area. Images were scored using a 5 point Likert scale by a qualified radiologist. The Results indicated that the images were of diagnostic quality. The proposed NeuViz Prime can be used as defined in its clinical workflow and intended use.
The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a head covering.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2017
NEUSOFT MEDICAL SYSTEMS CO., LTD. % Shao Xiancheng R&A No. 16, Shiji Road, Hunnan Industrial Area Shenvang, Liaoning 110179 P R CHINA
Re: K171201
Trade/Device Name: NeuViz Prime Multi-Slice CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 23, 2017 Received: August 25, 2017
Dear Shao Xiancheng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171201
Device Name
NeuViz Prime Multi-Slice CT Scanner System
Indications for Use (Describe)
The NeuViz Prime Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/0 description: The image shows the logo for Neusoft Medical Systems. The logo consists of the word "Neusoft" in blue, followed by the Chinese characters "东软医疗" in green. The Chinese characters translate to "Neusoft Medical". There is a registered trademark symbol above the "t" in Neusoft.
510(K) Summary
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92
General Information:
| Manufacturer: | Neusoft Medical Systems Co., Ltd.
No.177-1 Chuangxin Road, Hunnan District,
Shenyang, Liaoning, China, 110167. |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Contact : Shao Xiancheng
Title : RA Engineer
Tel : 86-24-83660645
Fax : 86-24-83660563
E-Mail : shaoxc@neusoft.com |
| 510(k) Summary Date
of Preparation: | August 21, 2017 |
Device Name and Classification:
| Trade Name: | NeuViz Prime Multi-Slice CT Scanner System |
|---|---|
| Common Name: | CT Scanner |
| Regulation: | 21 CFR 892.1750 |
| Classification Name: | Computed tomography x-ray system |
| Product Code: | JAK |
| Classification: | Class II |
| Performance Standard: | 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment |
| Standard |
Primary Predicate device:
| Trade Name: | NeuViz 128 Multi-Slice CT Scanner System |
|---|---|
| 510(k) number: | K151383 |
| Clearance Date: | 11/04/2015 |
| Regulation: | 21 CFR 892.1750 |
| Classification Name: | Computed tomography x-ray system |
| Product Code: | JAK |
| Classification: | Class II |
| Manufacturer: | Neusoft Medical Systems Co., Ltd. |
Reference Device:
| Trade Name: | GE LightSpeed CT750 HD (LightSpeed 8.0) (K081105). |
|---|---|
| 510(k) number: | K081105 |
| Clearance Date: | 05/09/2008 |
| Regulation: | 21 CFR 892.1750 |
| Classification Name: | Computed tomography x-ray system |
| Product Code: | JAK |
| Classification: | Class II |
| Manufacturer: | GE Medical Systems, LLC (GE Healthcare) |
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Image /page/4/Picture/0 description: The image shows the logo for Neusoft Medical Systems. The logo consists of the word "Neusoft" in blue, followed by the Chinese characters "东软医疗" in green. The Chinese characters translate to "Neusoft Medical". The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.
Reference Device:
| Trade Name: | IntelliSpace Portal Platform. |
|---|---|
| 510(k) number: | K162025 |
| Clearance Date: | 10/18/2016 |
| Regulation: | 21 CFR 892.2050 |
| Classification Name: | Picture archiving and communications system |
| Product Code: | LLZ |
| Classification: | Class II |
| Manufacturer: | Philips Medical Systems Nederland B.V |
Safety and Effectiveness information
Indications for use:
The NeuViz Prime Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Device Description:
The NeuViz Prime Multi-Slice CT Scanner System is composed of a gantry, a patient couch, an operator console and includes image acquisition hardware and software, and associated accessories. It is designed to be a head and whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) and iterative reconstruction algorithm(ClearView cleared in K133373) to reconstruct images. The end user can choose to apply either ClearView or the FBP to the acquired raw data. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. It provides the following digital image processing and visualization tools:
- · Support following scan speed: 0.259s(option), 0.32s(option), 0.374s(option), 0.4s(option), 0.5s, 0.6s, 0.8s, 1.0s, 1.5s, 2.0s.
- . Surview scan
- Dual surview
- Spiral scan
- Axial scan
- Image reconstruction
- Plan scan
- Patient information management
- Patient information registration
- Protocol selection
- O-Dose
- · Bolus tracking
- SAS
- Home
- Film
- Report
- 2D
5
Image /page/5/Picture/0 description: The image shows the logo for Neusoft Medical Systems. The logo is in blue and green. The text "Neusoft" is in blue, and the Chinese characters for "Dongruan Medical" are in green. There is a registered trademark symbol above the "t" in Neusoft.
- MPR
- 3D
- VE(Virtual Endoscopy)
- Vessel Analysis
- Dicom Viewer
- Bar code Reader
- Dual Monitor
- CCT Scan
- ClearView
- iHD
- Cardiac Scan
- Dual Energy Scan and Reconstruction ●
- Dental Analysis
- Virtual Colonoscopy
- Brain Perfusion
- Body Perfusion
- · Lung Nodule Analysis
- Lung Density Analysis
- · Coronary Analysis
- Cardiac Calcium Scoring .
- Cardiac Function Analysis
- Cardiac Viewer
- Fat Analysis
- CTDSA
- Tumor Assessment
- · Preprocessing function
- AVW.Cloud
- · Prism Viewer
Statement of Substantial Equivalence:
The NeuViz Prime Multi-Slice CT Scanner System has the same indications for use as the predicate device, NeuViz 128 Multi-Slice CT Scanner System (K151383). The NeuViz Prime is a computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The subject device does not have significant changes in technological characteristics when compared to the predicate device. The subject device and predicate device are the same in regards to:
- Detector/Tube system that can rotate continuously. The Tube emits X-ray beam of fan shape, detector system with multiple channels;
- Low voltage slip ring and On-Board HV Generator;
- Parallel data acquisition, simultaneous scan and image reconstruction;
- Gantry that may be tilted forward or backward;
- Patient Couch that can be elevated or lowered;
- Computerized control of scan and other operations;
- Computerized image reconstruction and post processing;
- Digitarized display, storage and output of data/image.
6
The design, intended use and technology provided with the subject device is equivalent to the Predicate device. A complete comparison table is included in this submission. See below for a brief comparison of the technological characteristics between the subject and the predicate devices:
| Item | NeuViz Prime | NeuViz 128 | Comments |
|---|---|---|---|
| 510(k) number | This submission | K151383 | NA |
| Indications for use | The NeuViz Prime | ||
| Multi-Slice CT | |||
| Scanner System | |||
| can be used as a | |||
| whole body | |||
| computed | |||
| tomography X-ray | |||
| system featuring a | |||
| continuously | |||
| rotating X-ray tube | |||
| and detector array. | |||
| The acquired | |||
| X-RAY | |||
| transmission data | |||
| is reconstructed by | |||
| computer into | |||
| cross-sectional | |||
| images of the body | |||
| from either the | |||
| same axial plane | |||
| taken at different | |||
| angles or spiral | |||
| planes taken at | |||
| different angles. | The NeuViz 128 | ||
| Multi-Slice CT | |||
| Scanner System can | |||
| be used as a whole | |||
| body computed | |||
| tomography X-ray | |||
| system featuring a | |||
| continuously rotating | |||
| X-ray tube and | |||
| detector array. | |||
| 510(k) The acquired | |||
| X-RAY transmission | |||
| data is | |||
| reconstructed by | |||
| computer into | |||
| cross-sectional | |||
| images of the body | |||
| from either the same | |||
| axial plane taken at | |||
| different angles or | |||
| spiral | |||
| planes taken at | |||
| different angles. | Identical | ||
| Application | Head/Body | Head/Body | Identical |
| Scan regime | Continuous | ||
| Rotation | Continuous Rotation | Identical | |
| Scan Modes | Surview | ||
| Spiral | |||
| Axial | Surview | ||
| Spiral | |||
| Axial | Identical |
7
| Gantry Aperture | 720mm | 720mm | Identical |
|---|---|---|---|
| Gantry Tilt | +/-30° | +/-30° | Identical |
| Detector Type | Solid-state | ||
| ceramic | Solid-state | ||
| ceramic | GOS Identical | ||
| Number of | |||
| Detector | |||
| Elements | 43,008 | 43,008 | Identical |
| Number of | |||
| Detector | |||
| Rows | 64 | 64 | Identical |
| Detector | |||
| Channels of | |||
| Per Row | 672 | 672 | Identical |
| Slice Thickness | Axial Scan:0.3125mm | ||
| (iHD Option) 、 | |||
| 0.625mm、1.25mm、 | |||
| 2.5mm、5mm、 | |||
| 10mm | |||
| Spiral Scan:0.4mm | |||
| (iHD Option)、 | |||
| 0.625mm、0.8mm、 | |||
| 1mm、1.25mm、 | |||
| 1.5mm、2.0mm、 | |||
| 3.0mm、4.0mm、 | |||
| 5.0mm、10mm | Axial Scan:0.3125mm | ||
| (iHD Option) 、 | |||
| 0.625mm、1.25mm、 | |||
| 2.5mm、5mm、 | |||
| 10mm | |||
| Spiral Scan:0.4mm(iHD | |||
| Option)、 | |||
| 0.625mm、0.8mm、 | |||
| 1mm、1.25mm、 | |||
| 1.5mm、2.0mm、 | |||
| 3.0mm、4.0mm、 | |||
| 5.0mm、10mm | Identical | ||
| CTDI Dose | Head 14.2 mGy/100 | ||
| mAs | |||
| Body 7.2 mGy/100 | |||
| mAs | Head 13.0 mGy/100 | ||
| mAs | |||
| Body 6.5 mGy/100 mAs | See Note1 | ||
| HV Power | |||
| (kW Output) | 100 | 80 | Increasing power provides same mAs during high gantry rotation. |
| mA Range | 10-833mA | 30-667mA | The impact of increasing the tube power is an extended mA range, difference in range does not affect safety and effectiveness. |
| kV Settings | 60,70,80,100,120,140 | 80,100,120,140 | Provides additional two settings that may be useful in standard scanning, does not affect safety and effectiveness. |
| Focal | |||
| spot | |||
| numbers | Three | Two | Provides another |
| focal spot setting | |||
| that may be useful | |||
| in standard | |||
| scanning, does not | |||
| affect safety and | |||
| effectiveness. | |||
| Maximum Anode | |||
| heat storage | Unlimited MHU | ||
| ( Effective Anode | |||
| Heat Content | |||
| 30MHU ) | 8MHU | New technology of | |
| Liquid metal | |||
| bearing have used, | |||
| and it disperse heat | |||
| as quickly as it is | |||
| generated. |
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Image /page/8/Picture/1 description: The image shows the logo for Neusoft. The logo is in blue and consists of the word "Neusoft" in a sans-serif font, with the Chinese characters for "Dongruan Medical" to the right of the word. There is a registered trademark symbol above the "t" in "Neusoft".
Note1: The subject device for a given protocol is approximately 10% higher than the CTDI for the matching protocol on the predicate device. Their protocols are the same. Because the beam filter and the wedge material of NeuViz 128 and NeuViz Prime are different. Differences are as follows.
| No | NeuViz 128 | NeuViz Prime | ||
|---|---|---|---|---|
| Filter Type | Equivalent aluminum(mm) | Type | Equivalent aluminum(mm) | |
| 1 | Tube | 1.5mm | Tube | >=4.8mm |
| 2 | Ti | 5.57mm | Ti | 2.79mm |
| 3 | Wedge(material is | 1.11mm at Thinnest | Wedge (material is | 1.11mm at Thinnest |
| Teflon) | 2a12 aluminum | |||
| alloy) |
The subject device and the predicate device, NeuViz 128 Multi-slice CT Scanner System (K151383) are the same in regard to most of application features.
A complete comparison table is included in this submission. The following table shows a brief comparison of the application features, including both similarities and differences among the subject and the predicate device.
| NeuViz Prime | NeuViz 128 |
|---|---|
| O-Dose | √ |
| Bolus tracking | √ |
| SAS | √ |
| Home | √ |
| Film | √ |
| Report | √ |
| 2D | √ |
| MPR | √ |
| 3D | √ |
| VE(Virtual Endoscopy) | √ |
| Vessel Analysis | √ |
| Dicom Viewer | √ |
| Bar code Reader | √ |
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| Dual Monitor | √ |
|---|---|
| CCT Scan | √ |
| ClearView | √ |
| iHD | √ |
| Cardiac Scan | √ |
| Dual Energy Scan and Reconstruction | X |
| Dental Analysis | √ |
| Virtual Colonoscopy | √ |
| Brain Perfusion | √ |
| Body Perfusion | √ |
| Lung Nodule Analysis | √ |
| Lung Density Analysis | √ |
| Coronary Analysis | √ |
| Cardiac Calcium Scoring | √ |
| Cardiac Function Analysis | √ |
| Cardiac Viewer | √ |
| Fat Analysis | √ |
| CTDSA | √ |
| Tumor Assessment | √ |
| Preprocessing function | √ |
| AVW.Cloud | X |
| Prism Viewer | X |
| "√" symbol means the comparable type and substantially | |
| equivalent to the contrasted devices. | |
| "x" symbol means the new clinical functionality. | |
| The application of "Prism Viewer" provides dual energy images | |
| visualization and measurement tools. The main functions include | |
| decomposing basis material, displaying various image, generating | |
| the best contrast noise ratio image and analyzing material | |
| composition. The main algorithm of Prism Viewer Application is | |
| identifying of substances and calculating of dual energy images. | |
| The Prism Viewer software package has the same intended use | |
| and operating principle as GSI Viewer of GE LIGHTSPEED CT750 |
rating princip HD (LIGHTSPEED 8.0).
There are some slight differences in application features between the NeuViz Prime and NeuViz 128. A complete comparison table is included in this submission. NeuViz Prime does not have significant differences in technological characteristics when compared to the predicate device NeuViz 128. The Indication for Use, operating principle, and the scientific technology are similar. According to the comparison based on the requirements of 21 CFR 807.87, we stated that these devices are substantially equivalent.
Nonclinical Testing:
The safety and effectiveness of the NeuViz Prime was assured by adherence to Good Manufacturing Practices(GMP) 21CFR 820 and to International Standards ISO 13485:2003. This device is in conformance with the applicable parts of the following standards:
- ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012 medical electrical equipment -- part 1: general requirements for basic safety and essential performance
- IEC 60601-1-2: 2007, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard:
10
Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-3: 2013, Medical Electrical Equipment - Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-Ray Equipment
- IEC 60601-1-6: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-28: 2010, Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- IEC 60601-2-44: 2012, Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Computed Tomography
- IEC 60825-1:2007, Safety of laser products part 1: equipment classification, ● and requirements
- IEC 61223-3-5: 2004, Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment
- AAMI ANSI IEC 62304:2006, Medical device software - Software life-cycle processes
- IEC 62366:2014,Medical Devices - Application Of Usability Engineering To Medical Devices
- ISO 10993-1: 2009, Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
- ISO 14971:2007, Medical devices – Application of risk management to medical devices
- NEMA PS 3.1 - 3.20 (2016), Digital Imaging And Communications In Medicine (DICOM) Set
- NEMA XR 25: 2010, Computed tomography dose check
- NEMA XR 28: 2013, Supplemental Requirements for User Information and System Function Related to Dose in CT
Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled during product development, and verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Neusoft adheres to recognized and established industry practice and standards.
Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements if demonstrated via testing. Testing included functional, smoke and regression tests. The vast majority of tests passed our testing criteria. Any defects found or reported were either fixed or logged in the Unresolved Anomalies report included with this submission and annotated as to any impact on safety or effectiveness including applicable workarounds. The traceability between design requirements, design specifications, testing requirements, and relevant hazards with the implementation and testing of the mitigations are described in the Traceability Matrix. The Traceability Matrix also shows the overall test results per requirement and per hazard mitigation.
Cybersecurity requirements is assured by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use
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Image /page/11/Picture/1 description: The image contains the logo for Neusoft Medical Systems. The logo features the word "Neusoft" in blue, followed by the Chinese characters "东软医疗" which translates to "Neusoft Medical". The logo is simple and clean, with a focus on the company name.
of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with quidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
Verification and validation activities(including performance testing, safety testing and simulated use testing) was performed. Some of the bench tests included the sag and the speed of patient support table, the gantry wobble, CT image quality metrics testing including CT number accuracy and uniformity, MTF, noise, slice sensitivity profiles and CTDI. Sample images were provided to show the performance of the system in presence of implants.
The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
clinical Testing:
The clinical validation plan identified the tasks, deliverables, methodology, requirements and the resources for validation of the intended use and meets customer needs. The clinical validation covered requirements related to clinical workflows and features. The validation was executed as planned and acceptance criteria met for each requirement. All validation tests demonstrate the safety and effectiveness of NeuViz Prime.
The results of the validation are available in the Clinical Validation Summary. Two CT clinical specialists of Neusoft validated the system under simulative clinical circumstances. An imaqe evaluation was performed to evaluate images of the brain, chest, abdomen and spine/extremities of the body area. Images were scored using a 5 point Likert scale by a qualified radiologist. The Results indicated that the images were of diagnostic quality. The proposed NeuViz Prime can be used as defined in its clinical workflow and intended use.
Conclusions:
According to the comparison based on the requirements of 21.CFR 807.87, We state that the subject device and the predicate device are substantially equivalent.